A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement
ISRCTN | ISRCTN58128724 |
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DOI | https://doi.org/10.1186/ISRCTN58128724 |
Secondary identifying numbers | 7766 |
- Submission date
- 24/06/2010
- Registration date
- 24/06/2010
- Last edited
- 01/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Sukumaran Nair
Scientific
Scientific
Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
Study information
Study design | Single-centre randomised interventional treatment trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement |
Study acronym | MiniStern Trial |
Study objectives | MiniStern is a pragmatic, prospective randomised controlled trial comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR). |
Ethics approval(s) | MREC approved (ref: 09/H0301/58) |
Health condition(s) or problem(s) studied | Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Surgery |
Intervention | Comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR). |
Intervention type | Procedure/Surgery |
Primary outcome measure | Total length of stay in hospital for the index AVR operation measured in days |
Secondary outcome measures | 1. Fitness for discharge 2. Health related quality of life and patient satisfaction at baseline, 6 weeks, 6 months and 12 months using the 36-item short form health survey (SF-36) and Coronary Revascularization Outcome Questionnaire - Coronary Artery Bypass Graft (CROQ-CABG) 3. Heart function (LVEF) by echocardiography at baseline, day of discharge and 6 months post surgery 4. Procedure time: total theatre time, cross clamp time, cardiopulmonary bypass time, blood loss, blood transfusion 5. Respiratory function (forced expiratory volume in one second [FEV1]) by hand held spirometry at baseline, day 4, day of discharge, 6 weeks and 6 months |
Overall study start date | 30/11/2009 |
Completion date | 01/09/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned sample size: 240 |
Total final enrolment | 222 |
Key inclusion criteria | 1. Aged greater than 18 years at the time of surgery, either sex 2. Elective, first time, isolated aortic valve replacement (AVR) |
Key exclusion criteria | 1. Documented poor left ventricular (LV) function or left ventricular ejection fraction (LVEF) 30% 2. Documented chest wall deformities 3. Documented severe emphysema or chronic obstructive pulmonary disease (COPD) 4. Current body mass index (BMI) greater than 35 kg/m^2 5. Concomitant cardiac surgery 6. Redo surgery 7. Median sternotomy indicated |
Date of first enrolment | 30/11/2009 |
Date of final enrolment | 01/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Papworth Hospital NHS Foundation Trust
Cambridge
CB23 3RE
United Kingdom
CB23 3RE
United Kingdom
Sponsor information
Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom
Website | http://www.papworthhospital.nhs.uk/index.php |
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https://ror.org/01qbebb31 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/12/2018 | 01/10/2019 | Yes | No |
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.